# FDA 483 - Abraxis Bioscience, LLC - October 06, 2023

Source: https://www.keypedia.com/records/483/abraxis-bioscience-llc/aa826ec4-8ed3-4488-80ea-38b12127d3a0

> FDA 483 for Abraxis Bioscience, LLC on October 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abraxis Bioscience, LLC
- Inspection Date: 2023-10-06
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Abraxis Bioscience, LLC, a sterile drug manufacturer in Phoenix, AZ, was cited with six observations during an FDA inspection from September 25 to October 6, 2023. The inspection revealed significant deficiencies across quality systems, including inadequate data integrity controls, incomplete investigations into out-of-specification results, and failures in maintaining aseptic processing equipment. Additional concerns involved insufficient secondary verification of laboratory records and poor management of reserve sample evaluations.

## Related Documents

- [483 - 2020-02-19](https://www.keypedia.com/records/483/abraxis-bioscience-llc/56322b10-4097-43ef-b961-9927ed0e18e9)
- [483 - 2022-04-06](https://www.keypedia.com/records/483/abraxis-bioscience-llc/250f83a6-29ae-4dc6-98ec-9e1f3087c8a8)

## Related Officers

- [Carrie A. Hughes](https://www.keypedia.com/people/carrie-a-hughes/099d1128-0ba9-4e7a-a0d2-8c10083811c9)
- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

Company: https://www.keypedia.com/companies/abraxis-bioscience-llc/5751a531-276f-4635-9289-30cacf498d86

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face